Novel treatment of patients with lower extremity ischemia: use of percutaneous atherectomy in 579 lesions.
OBJECTIVE
Endovascular options for the treatment of lower extremity peripheral arterial disease are typified with diminished patency. A novel alternative to standard angioplasty and stent is the excision of the obstructing arterial plaque using a minimally invasive technique, the Silverhawk Atherectomy device.


METHODS
A prospective database was maintained of SilverHawk procedures from 2004 to 2007. A total of 579 lesions were treated in 275 patients (claudication 101 patients (36.7%) and critical limb ischemia (CLI) in 174 patients (63.3%). Noninvasive laboratory evaluation was performed at 1, 3, and 6 months, and yearly. Stand-alone atherectomy was attempted, and adjunct therapy was used for residual stenosis.


RESULTS
Mean age was 70.0 years (range, 37-102) (62.5% male, 46.2% smokers, 67.6% diabetes mellitus). Lesion characteristics were 199 superficial femoral arteries, 110 popliteal, 218 tibials, and 52 multilevel. Thirty-day perioperative mortality was 1.8%. Mean follow-up was 12.5 months (range, 0.5-48.2). 18-month primary and secondary patency for all lesions was 52.7% +/- 2.8 and 75.0% +/- 2.4 (P < 0.0001). Eighteen-month primary and secondary patency for claudicants was 58.0% +/- 4.3 and 82.5% +/- 3.5 (P < 0.0001) and for CLI was 49.4% +/- 3.7 and 69.9% +/- 3.2 (P < 0.0001), respectively. The reintervention rate was 25.3% in claudicants and 30.1% for CLI. Limb salvage was 100% in claudicants and overall limb salvage was 92.4% per patient at 18 months and only 4.4% required bypass.


CONCLUSIONS
This is the largest reported series with the longest follow-up showing the SilverHawk device as an effective endovascular therapy for patients with claudication and CLI with a low mortality, low complications rate, low amputation rate, and rare need for conversion to surgical bypass. The majority of reintervention was performed with endovascular techniques.
McKinsey
James F
JF
Division of Vascular Surgery, New York Presbyterian Hospital, Columbia University, College of Physicians and Surgeons, New York, NY 10032, USA. jfm2111@columbia.edu
Goldstein
Lee
L
Khan
Habib U
HU
Graham
Ashley
A
Rezeyat
Combiz
C
Morrissey
Nicholas J
NJ
Sambol
Elliott
E
Kent
K Craig
KC
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D017073:Atherectomy / Q000379:methods*; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D005500:Follow-Up Studies; D006801:Humans; D007511:Ischemia / Q000000981:diagnostic imaging / Q000601:surgery*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery / Q000000981:diagnostic imaging / Q000601:surgery*; D012189:Retrospective Studies; D016909:Tibial Arteries / Q000000981:diagnostic imaging / Q000601:surgery*; D016896:Treatment Outcome